Why it was recalled
Failed pH Specifications: product was too acidic.
Product description
Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25.
Lot numbers, UPCs & expiration codes
Lot #: S2611I28 (exp 9/16), S2511I14 (exp 9/16), S2531I16 (exp 9/16), S2721J21 (exp 10/16), S2871K03 (exp 11/16), S2881K03 (exp 11/16), and S2931K07 (exp 11/16).
Where it was sold
To wholesale distributors and retailers located Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1262-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 7, 2014
- FDA report date
- May 7, 2014
- Quantity
- 12,600 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Piramal Critical Care, Inc.
Original FDA data
Every field from FDA enforcement report D-1262-2014, exactly as published.
Show all FDA fields
- City
- Bethlehem
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 68004
- Address
- 3950 Schelden Cir
- Code information
- Lot #: S2611I28 (exp 9/16), S2511I14 (exp 9/16), S2531I16 (exp 9/16), S2721J21 (exp 10/16), S2871K03 (exp 11/16), S2881K03 (exp 11/16), and S2931K07 (exp 11/16).
- Postal code
- 18017-8936
- Report date
- May 7, 2014
- Product type
- Drugs
- Recall number
- D-1262-2014
- Classification
- Class II
- Recalling firm
- Piramal Critical Care, Inc.
- Product quantity
- 12,600 bottles
- Termination date
- Dec 15, 2014
- Reason for recall
- Failed pH Specifications: product was too acidic.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25.
- Distribution pattern
- To wholesale distributors and retailers located Nationwide.
- Recall initiation date
- Apr 7, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2014